- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Alkem Labs gets 1 observation from USFDA for Indore facility
New Delhi: Alkem Laboratories Limited has recently announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with one observation after inspecting its Indore facility.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The inspection was conducted from 01st July 2022 to 07th July 2022.
"This is to inform you that USFDA had conducted a GMP and Pre-Approval inspection at the Company's manufacturing facility located at Indore from 01st July, 2022 to 07th July, 2022," Alkem said in a BSE filing.
Read also: Alkem launches inhalation device Innohaler for Asthma, COPD patients
At the end of the inspection, the Company has received Form 483 with one observation with respect to Abbreviated New Drug Application (ANDA) filed for the products to be manufactured at the said plant. There is no data integrity observation.
"This GMP and Pre-Approval Inspection is part of the routine business operations and the Company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said observation," Alkem labs added.
Alkem Labs is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company was founded by Samprada Singh in 1973. The company's portfolio includes illustrious brands like Clavam, Pan, Pan-D and Taxim-O.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751